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The Tända Max OTC System is intended to be used for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

The Tända Max OTC System is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, AC adapter, and goggles. The Tända Max OTC System utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

Based on the provided text, the Tända Max OTC System is a light therapy device intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for de novo device approval.

Therefore, the information available is limited regarding specific acceptance criteria and the detailed methodology of the clinical study. However, I can extract the available information and highlight what is not present.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state specific quantitative acceptance criteria for clinical efficacy (e.g., "X% reduction in wrinkle depth"). Instead, it broadly states that "A clinical evaluation was successfully performed and the results of which are provided in this application." This implies that the clinical evaluation demonstrated a positive outcome consistent with the intended use, but the specific metrics and targets are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only mentions "A clinical evaluation was successfully performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the text. Given the nature of wrinkle treatment, ground truth for efficacy would typically be established by dermatologists or plastic surgeons, but the number and qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided in the text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was mentioned or implied. This device is a light therapy device, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the Tända Max OTC System is a physical light therapy device, not a software algorithm. Its performance is inherent in its direct application and physiological effect, not in an interpretive algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The specific type of ground truth used to assess the efficacy of wrinkle reduction is not explicitly stated. For wrinkle treatment, this typically involves photographic analysis, grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales), and possibly patient self-assessment, often evaluated by expert clinicians (dermatologists/plastic surgeons). The summary only states "A clinical evaluation was successfully performed."

8. The sample size for the training set

• This information is not provided in the text.
• Note: For a medical device like this, the term "training set" is usually not applicable in the same way it is for machine learning algorithms. If there was any "training" data, it would refer to data used during early R&D or pilot studies, which are distinct from the formal clinical evaluation.

9. How the ground truth for the training set was established

• This information is not provided and is largely not applicable in the context of this device as explained in point 8.

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The Tända Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Tända Max is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, Pre-treatment gel, AC adapter and goggles.

Tända Max utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

The provided text describes the Tända Max System, an LED light system intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. However, the document explicitly states that "additional clinical information is not necessary" and therefore no clinical study was performed to demonstrate device effectiveness.

The submission focuses primarily on comparing the Tanda Max System to predicate devices based on technological characteristics and non-clinical testing.

Given this, I cannot provide detailed information for many of your requested points as a clinical study proving the device meets acceptance criteria was not conducted or reported in this document.

Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance metrics from such a study. The "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices and adherence to non-clinical safety standards.

Study Details (Not Applicable/Information Not Provided):

1. Sample size used for the test set and the data provenance: Not applicable, no clinical test set mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set mentioned.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, no clinical study was done, and this device is not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no standalone performance study was done as it's not an algorithm-only device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth established or used.
7. The sample size for the training set: Not applicable, no training set for a clinical study or AI algorithm mentioned.
8. How the ground truth for the training set was established: Not applicable, no training set or ground truth established.

Summary of Determination:

The FDA's review concluded that the Tända Max System is substantially equivalent to legally marketed predicate devices based on its intended use, technological characteristics (output, wavelength, treatment duration, regimen), and adherence to safety and biocompatibility standards. This substantial equivalence determination allowed the device to be marketed without requiring new clinical data, as explicitly stated in section 9: "Based on the above information, additional clinical information is not necessary."

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The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.

Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.

The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.

This is a 510(k) premarket notification for a medical device (K090008) which often relies on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically associated with novel or high-risk devices.

Based on the provided document, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance & 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No specific acceptance criteria or performance metrics table is provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence.
• No MRMC comparative effectiveness study or standalone AI algorithm performance study was performed or reported. This device is an infrared therapeutic heating lamp, not an AI-powered diagnostic or assistive technology.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. The submission does not describe a clinical study or a test set in the context of evaluating diagnostic or algorithmic performance. The device is an infrared lamp.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. There is no "ground truth" to establish for a test set in this context, as it's not a diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. The device is an infrared lamp for therapeutic heating; it does not generate diagnostic data for which "ground truth" would be established. The "ground truth" here would be the physical properties and safety of the device itself.

8. The sample size for the training set & 9. How the ground truth for the training set was established:

• Not applicable. This device is not an AI/ML algorithm that requires training data or a training set.

Summary of Device Acceptance and Supporting Information from the Document:

The acceptance of the Tända Restore System is based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance criteria from a clinical trial.

Here's the relevant information provided:

• Device Name: Tända Restore™
• Intended Use: An over-the-counter device for temporary relief of minor aches and pains in muscles and joints, and whenever recommended by a licensed medical professional for hot applications. It aims to emit energy in the infrared spectrum to provide topical heating for elevating/maintaining tissue temperature, temporary relief of minor muscular pain, joint pain & stiffness, muscle relaxation, improved range of motion, and temporary increase in local blood circulation.
• Regulatory Status: Class II medical device, Product Code ILY, Regulation Number 890.5500 (Infrared Lamp).

Basis for Acceptance (Substantial Equivalence):

• Predicate Devices:
  • Light Relief Pain Relief Device (Light Relief, LLC, K070974)
  • MedX (MedX Health Corp, K020017)
  • Quantum WARP 10 Light Delivery System (Quantum Devices, K032229)
• Comparison of Technological Differences: The document states: "The intended use and technological characteristics of the Tanda Restore are virtually identical to the combined intended uses and technological characteristics of the listed equivalent predicate devices. Any differences between the Tanda Restore System and the equivalent devices have no significant influence on the safety or effectiveness of the Tanda Restore System."
• Additional Safety Data:
  • The Tända Restore System underwent certification to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
  • Testing and analysis demonstrated compliance to ISO 10993 (Biological evaluation of medical devices - Biocompatibility).

Conclusion based on the provided document:

The FDA determined the Tända Restore™ device to be substantially equivalent to its predicate devices, primarily based on its shared intended use, similar technological characteristics (infrared lamp emitting 870 nm), and compliance with recognized safety and biocompatibility standards (IEC 60601-1 and ISO 10993). There was no need for clinical trial-based acceptance criteria or performance metrics as it's a therapeutic heating lamp demonstrating equivalence, not a novel diagnostic tool.

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The Tända Skincare System is intended as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

The Tanda Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.

The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.

The provided text describes the Tända Skincare System, its intended use, and a limited amount of information regarding safety data. However, it does not contain specific acceptance criteria for performance, nor does it detail a study that proves the device meets such criteria. The document focuses on regulatory approval (510(k) summary) and substantial equivalence to previously cleared devices.

Therefore, I cannot fully answer your request as the necessary information is not present in the provided text.

Based on the available text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not provided in the text.
• Reported Device Performance: The text states, "A clinical Study... was undertaken and shown to demonstrate that the Tända Skincare System can be used safely as a nonprescription device." This is a general statement about safety, not performance criteria or specific performance metrics (e.g., reduction in acne lesions, percentage of responders). There are no quantitative measures of effectiveness mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). It only mentions "A clinical Study under the supervision of a Health Care practitioner (MD)".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not provided. The text only mentions the study was "under the supervision of a Health Care practitioner (MD)."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a phototherapy system, not an AI-assisted diagnostic device. The study described focuses on the device's own safety as a standalone product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This refers to the device's performance as a standalone product, which is implied by the clinical safety study. However, specific performance metrics for "standalone" effectiveness are missing. The statement "can be used safely as a nonprescription device" focuses on safety, not efficacy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not provided. Given it's a treatment for acne, typical outcomes data (e.g., lesion count reduction, global assessment scores) would be relevant, but none are specified as "ground truth."

8. The sample size for the training set

• Not applicable. This device does not appear to involve AI/machine learning models that require a "training set."

9. How the ground truth for the training set was established

• Not applicable for the same reason as point 8.

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The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.

The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.

The provided 510(k) summary (K070185) for the Tända Skincare System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) and detailing safety certifications.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred/stated based on the provided document:

1. Table of acceptance criteria and the reported device performance

The 510(k) summary does not mention specific quantitative acceptance criteria for treating acne or report detailed device performance metrics in relation to such criteria. The document states the device's intended use is "to treat Acne" and indicates that "Blue light modules are indicated to treat mild to moderate inflammatory acne."

2. Sample sized used for the test set and the data provenance

Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not mentioned in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not mentioned in the document. This device is not an AI-based system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is a light therapy device, not an algorithm. Performance assessment typically involves clinical studies on patients, which are not described here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not mentioned in the document. For a physical therapy device like this, ground truth would typically refer to clinical improvement or clearance of acne based on dermatologist assessment or objective metrics.

8. The sample size for the training set

Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established

Not applicable/mentioned.

Summary of what is present in the document regarding "proof" of meeting criteria:

The document focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) based on "virtually identical" intended use and technological characteristics. It also states that "Any differences... have no significant influence on safety or effectiveness."

Additionally, it provides safety data demonstrating compliance with:

• IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
• ISO 10993 (Biocompatibility)
• IEC 60825-1 (Laser Safety), with an Accessible Emission Limit (AEL) below the Class I threshold.
• Evaluation of ocular hazard levels, concluding no risk of retinal injury from blue-light phototoxic effect, thermal damage, or additive effects.

These safety certifications and comparisons to the predicate device form the basis for the FDA's 510(k) clearance, indicating that the device is deemed as safe and effective as the legally marketed predicate. However, it does not detail specific clinical performance criteria or a study that quantitatively measures the device's efficacy against those criteria.

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